Registration Dossier
Registration Dossier
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EC number: 605-146-4 | CAS number: 158451-78-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- non-GLP
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- other: Off. J. Europ. Commun. L 257, 83/467/EEC
- Version / remarks:
- September 16, 1983
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Register Vol.38, No. 187, §1500.41
- Version / remarks:
- September 9, 1973
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,6-Hexanediamine, N1,N1,N6,N6-tetramethyl-, propoxylated (>1 < 4,5 mol PO)
- EC Number:
- 605-146-4
- Cas Number:
- 158451-78-6
- Molecular formula:
- C16H38N2O2
- IUPAC Name:
- 1,6-Hexanediamine, N1,N1,N6,N6-tetramethyl-, propoxylated (>1 < 4,5 mol PO)
Constituent 1
- Specific details on test material used for the study:
- - Delivery: shortly before treatment
- Aggregate state at 20°C: liquid
- Colour: yellowish
- Content of active substance: 20%
- Stability: not stable by acids
- Storage: room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- males
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fortkamp, Lengerich/D
- Weight at study initiation: approx. 4400 g
- Housing: individual cage accomodation
- Diet: Altromin 2023
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: the right, respectively left flank of each animal was sheared approx. 24 hour prior to application
- Type of wrap if used: air- and vapour permeable gauze-patch (6 cm2), fixed by a gauze-bandage
REMOVAL OF TEST SUBSTANCE
- Washing: skin was cleaned using a tissue moistened with tap water and subsequently a dry tissue
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after exposure
SCORING SYSTEM:
- Method of calculation: the skin was scored according to the OECD scoring system. Mean values of scores from 24-72 hours were taken for the classification.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritant / corrosive response data:
- Severe erythema were observed at two experimental animals during the 1-hour-observation. One of the experimental animal showed a slight edema at the 1-hour-observation. Both of the experimental animals showed beginning necrosis. After 24, 48 and 72 hours severe erythema, slight edema and necrosis were observed at the two experimental animals. The study aborted after 72 hours, because of the strong reactions. The animals were sacrificed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
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